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Company: Kelly Services
Location: Cincinnati, OH
Career Level: Associate
Industries: Recruitment Agency, Staffing, Job Board

Description

Senior Analyst, QC Chemist
Day shift
Cincinnati, OH Area

Seeking a Senior Analyst, QC Chemist in a pharmaceutical GMP (Good Manufacturing Practice) environment.  This role will perform analytical testing for various samples including but not limited to in-process, finished product, stability, raw material, cleaning verification/validation, and development and validation samples.  Performs data review. Participates in laboratory investigations, related to QC processes or data. Supports validation, method development and transfer activities, trains QC employees, supports laboratory equipment qualifications, investigations and change control management.
Job Responsibilities:

  • Analytical Testing:
    • Performing complex analytical tests on a wide variety of samples (in-process, finished product, stability, raw materials, etc.).
    • Utilizing various analytical techniques, with a strong emphasis on HPLC/GC.
  • Data Review and GMP Compliance:
    • Conducting thorough GMP reviews of laboratory documentation, including electronic data.
    • Ensuring compliance with SOPs, test methods, regulations, and protocols.
    • Communicating findings and following up on corrections.
  • Quality Investigations and Troubleshooting:
    • Participating in laboratory investigations, including OOS (Out of Specification) and atypical events.
    • Performing root cause analysis and ensuring accurate documentation.
    • Troubleshooting methods and processes.
  • Method Development and Validation:
    • Supporting validation, method development, and transfer activities.
    • Actively supporting the implementation of compendial changes (USP/NF, etc.).
  • Equipment Management:
    • Maintaining and troubleshooting testing equipment.
    • Supporting laboratory equipment qualifications, investigations, and change control.
  • Training and Mentorship:
    • Training QC employees in analytical techniques, methods, instrumentation, GMP, and SHE (Safety, Health, and Environment).
  • Continuous Improvement:
    • Evaluating data trends and identifying areas for continuous improvement.
    • Leading continuous improvements in laboratory processes.
Key Skills and Qualifications:
  • Analytical Expertise:
    • Extensive analytical experience in a pharmaceutical GMP facility.
    • Proficiency with HPLC/GC and chromatography software (e.g., Empower).
  • GMP Knowledge:
    • Strong understanding of GMP regulations and quality control principles.
  • Problem-Solving and Communication:
    • Ability to troubleshoot methods and processes.
    • Excellent communication and documentation skills.
    • Ability to perform root cause analysis.
  • Regulatory Knowledge:
    • Knowledge of Pharmacopoeias such as USP/NF, European Pharmacopoeia, British, and Japanese Pharmacopoeia is a plus
Job Details:
  • Temp-to-Hire
  • $87K+/Negotiable; DOE
  • Competitive salary; Full Benefits Package
  • 2-2-3 work schedule/6am-6pm Monday-Thursday

In essence, this is a senior-level analytical role requiring a strong foundation in pharmaceutical quality control, analytical chemistry, and GMP compliance.   If interested, please submit your resume for immediate consideration.

 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.


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